[Federal Register Volume 79, Number 243 (Thursday, December 18, 2014)]
[Proposed Rules]
[Pages 75528-75529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29647]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 88


World Trade Center Health Program; Petition 006--Primary Biliary 
Cirrhosis; Finding of Insufficient Evidence

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Denial of petition for addition of a health condition.

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SUMMARY: On October 20, 2014, the Administrator of the World Trade 
Center (WTC) Health Program received a petition to add primary biliary 
cirrhosis (Petition 006) to the List of WTC-Related Health Conditions 
(List). The Administrator has not found sufficient scientific evidence 
to conduct an analysis of whether to add primary biliary cirrhosis to 
the List. Accordingly, the Administrator finds that insufficient 
evidence exists to request a recommendation of the WTC Health Program 
Scientific/Technical Advisory Committee (STAC), to publish a proposed 
rule, or to publish a determination not to publish a proposed rule.

DATES: The Administrator of the WTC Health Program is denying this 
petition for the addition of a health condition as of December 18, 
2014.

FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst, 1090 
Tusculum Ave., MS: C-46, Cincinnati, OH 45226; telephone (855)818-1629 
(this is a toll-free number); email [email protected].

SUPPLEMENTARY INFORMATION:

A. WTC Health Program Statutory Authority

    Title I of the James Zadroga 9/11 Health and Compensation Act of 
2010 (Pub. L. 111-347), amended the Public Health Service Act (PHS Act) 
to add Title XXXIII \1\ establishing the WTC Health Program within the 
Department of Health and Human Services (HHS). The WTC Health Program 
provides medical monitoring and treatment benefits to eligible 
firefighters and related personnel, law enforcement officers, and 
rescue, recovery, and cleanup workers who responded to the September 
11, 2001, terrorist attacks in New York City, at the Pentagon, and in 
Shanksville, Pennsylvania (responders), and to eligible persons who 
were present in the dust or dust cloud on September 11, 2001 or who 
worked, resided, or attended school, childcare, or adult daycare in the 
New York City disaster area (survivors).
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    \1\ Title XXXIII of the PHS Act is codified at 42 U.S.C. 300mm 
to 300mm-61. Those portions of the Zadroga Act found in Titles II 
and III of Public Law 111-347 do not pertain to the WTC Health 
Program and are codified elsewhere.
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    All references to the Administrator of the WTC Health Program 
(Administrator) in this notice mean the Director of the National 
Institute for Occupational Safety and Health (NIOSH) or his or her 
designee.
    Pursuant to section 3312(a)(6)(B) of the PHS Act, interested 
parties may petition the Administrator to add a health condition to the 
List in 42 CFR 88.1. Within 60 calendar days after receipt of a 
petition to add a condition to the List, the Administrator must take 
one of the following four actions described in section 3312(a)(6)(B) 
and 42 CFR 88.17: (i) Request a recommendation of the STAC; (ii) 
publish a proposed rule in the Federal Register to add such health 
condition; (iii) publish in the Federal Register the Administrator's 
determination not to

[[Page 75529]]

publish such a proposed rule and the basis for such determination; or 
(iv) publish in the Federal Register a determination that insufficient 
evidence exists to take action under (i) through (iii) above.

B. Petition 006

    On October 20, 2014, the Administrator received a petition to add 
primary biliary cirrhosis to the List (Petition 006).\2\ The petition 
was submitted by a Salvation Army responder who worked at Ground Zero 
in the aftermath of the September 11, 2001, terrorist attacks. The 
petitioner stated that she had been diagnosed with primary biliary 
cirrhosis and shared letters from her personal physicians confirming 
the diagnosis. The petition offered as evidence a number of articles 
identifying potential associations between primary biliary cirrhosis 
and other autoimmune diseases to various environmental exposures, 
including polycyclic aromatic hydrocarbons, xenobiotics, asbestos, and 
silicon.\3\
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    \2\ See Petition 006. WTC Health Program: Petitions Received. 
http://www.cdc.gov/wtc/received.html.
    \3\ Smyk D, Mytilinaiou MG, Rigopoulou EI, Bogdanos DP [2010]. 
PBC triggers in water reservoirs, coal mining areas and waste 
disposal sites: from Newcastle to New York. Disease Markers 29:337-
344; Pleil JD, Vette AF, Johnson BA, Rappaport SM [2004]. Air levels 
of carcinogenic polycyclic aromatic hydrocarbons after the World 
Trade Center disaster. PNAS 101(32):11685-11688; Dronamraju D, Odin 
J, Bach N [2010]. Primary biliary cirrhosis: environmental risk 
factors. Disease Markers 29:323-328; Selmi C, De Santis M, 
Cavaciocchi F, Gershwin ME [2010]. Infectious agents and xenobiotics 
in the etiology of primary biliary cirrhosis. Disease Markers 
29:287-299; September 11th Worker Protection Task Force. Interim 
Report. March 4, 2008; Walsh N [2014]. Asbestos revisited: a new 
autoimmune disease? MedPage Today at http://www.medpagetoday.com/Rheumatology/GeneralRheumatology/46972; Speck-Hernandez CA and 
Montoya-Ortiz G [2012]. Silicon, a possible link between 
environmental exposure and autoimmune diseases: the case of 
rheumatoid arthritis. Arthritis at http://dx.doi.org/10.1155/2012/604187.
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C. Administrator's Determination on Petition 006

    The Administrator has established a methodology for evaluating 
whether to add non-cancer health conditions to the List of WTC-Related 
Health Conditions.\4\ First, the Administrator determines whether 
published, peer-reviewed studies about the health condition among 9/11-
exposed populations are available to assess evidence for a causal 
relationship and provide a basis for a decision on whether to add the 
condition to the List. If the studies provide sufficient evidence for 
analysis, the Administrator proceeds with an assessment of the 
information. A health condition may be added to the List if published, 
peer-reviewed direct observational or epidemiologic studies provide 
substantial support \5\ for a causal relationship between 9/11 
exposures and the health condition in 9/11-exposed populations. If only 
epidemiologic studies are available and they provide only modest 
support \6\ for a causal relationship between 9/11 exposures and the 
health condition, the Administrator may then evaluate studies of 
associations between the health condition and 9/11 agents.\7\ If that 
additional assessment establishes substantial support for a causal 
relationship between a 9/11 agent or agents and the health condition, 
the health condition may be added to the List.
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    \4\ This methodology, ``Policy and Procedures for Adding Non-
Cancer Conditions to the List of WTC-Related Health Conditions,'' 
revised October 21, 2014, is available on the WTC Health Program Web 
site, at http://www.cdc.gov/wtc/policies.html.
    \5\ The substantial evidence standard is met when the Program 
assesses all of the available, relevant information and determines 
with high confidence that the evidence supports its findings 
regarding a causal association between the 9/11 exposure(s) and the 
health condition.
    \6\ The modest evidence standard is met when the Program 
assesses all of the available, relevant information and determines 
with moderate confidence that the evidence supports its findings 
regarding a causal association between the 9/11 exposure(s) and the 
health condition.
    \7\ 9/11 agents are chemical, physical, biological, or other 
agents or hazards reported in a published, peer-reviewed exposure 
assessment study of responders or survivors who were present in 
either the New York City disaster area, the Pentagon site, or in 
Shanksville, Pennsylvania site as defined in 42 CFR part 88.
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    In accordance with section 3312(a)(6)(B) of the PHS Act and 42 CFR 
88.17, described above, the Administrator has reviewed the evidence 
presented in Petition 006. None of the articles presented with the 
petition provide sufficient evidence of a causal relationship between 
primary biliary cirrhosis and 9/11 exposures to establish a basis for a 
decision on whether to add primary biliary cirrhosis to the List. 
Although some of the articles identify potential associations between 
specific 9/11 agents and primary biliary cirrhosis or autoimmune 
disease in general, none of the articles are peer-reviewed direct 
observational or epidemiologic studies of 9/11 populations, as required 
by the methodology described above.
    In addition to reviewing the evidence provided in Petition 006, the 
Administrator also conducted a search of the existing scientific/
medical literature for evidence that could establish a causal 
relationship between 9/11 exposures and primary biliary cirrhosis. He 
did not find any peer-reviewed, published direct observational or 
epidemiologic studies of 9/11-exposed populations which would support 
such a relationship.
    Because neither the evidence submitted by the Petitioner nor a 
search of published scientific/medical literature provided information 
regarding the occurrence of primary biliary cirrhosis among 9/11-
exposed populations, the Administrator has determined that requesting a 
recommendation from the STAC (pursuant to PHS Act, section 
3312(a)(6)(B)(i) and 42 CFR 88.17(a)(2)(i)) is unwarranted. In prior 
actions, the Administrator requested a recommendation from the STAC 
when he determined that it would assist his evaluation; such as when, 
for example, the Administrator is in need of an interpretation of 
conflicting or inconclusive published scientific evidence.
    Similarly, the Administrator has determined that insufficient 
evidence exists to take further action, including either proposing the 
addition of primary biliary cirrhosis to the List (pursuant to PHS Act, 
section 3312(a)(6)(B)(ii) and 42 CFR 88.17(a)(2)(ii)) or publishing a 
determination not to publish a proposed rule in the Federal Register 
(pursuant to PHS Act, section 3312(a)(6)(B)(iii) and 42 CFR 
88.17(a)(2)(iii)). In order to publish such a proposed addition or a 
determination not to propose a rule, the Administrator would first need 
to find that enough scientific evidence is available to analyze whether 
9/11 exposures are associated with the health condition. Since the 
Administrator is unable to identify sufficient evidence to conduct an 
analysis of whether to add the health condition, the Administrator 
(pursuant to PHS Act, section 3312(a)(6)(B)(iv) and 42 CFR 
88.17(a)(2)(iv)) is publishing a determination that he cannot take any 
of the other statutory and regulatory actions.
    For the reasons discussed above, the request made in Petition 006 
to add primary biliary cirrhosis to the List of WTC-Related Health 
Conditions is denied.

    Dated: December 10, 2014.
John Howard,
Administrator, World Trade Center Health Program and Director, National 
Institute for Occupational Safety and Health, Centers for Disease 
Control and Prevention, Department of Health and Human Services.
[FR Doc. 2014-29647 Filed 12-17-14; 8:45 am]
BILLING CODE 4163-18-P